Vaccine. 2013 Oct 17;31(44):5041-6. doi: 10.1016/j.vaccine.2013.08.087. Epub 2013 Sep 8.
Assessment of causality of individual adverse events following immunization (AEFI): a WHO
tool for global use.
Tozzi AE1, Asturias EJ, Balakrishnan MR, Halsey NA, Law B, Zuber PL.
Jacob Puliyel 2014 Mar 18 12:28 p.m.
Dr Malik, as part of the India Government Ministry of Health, has information on the AEFIs withPentavalent vaccine and their investigation. I mention individual instances because Dr Malik isfamiliar with them and it best illustrates the harm done by the new system of AEFIclassification.
Of the 54 deaths reported to the Government of India some have been investigated and theAEFI reports are available here
The deaths as described below could well have been caused by ‘multisystem generalized
reaction to one or more vaccine components’ (page 50 of the CIOMS/WHO report). But a casedefinition for this entity has not been developed as yet by the Brighton group. When such
multisystem reactions occur they appear like the multiple organ dysfunction syndrome (MODS)
that follow sepsis but it must not be confused with it. The AEFI committee assumes that all
MODS are due to due to sepsis or, if it is associated with unconsciousness, it must be
meningitis/encephalitis. The new AEFI algorithm seems to promote and propagate thisconfusion.
1) The manner in which the deaths are declared as unrelated to the vaccine is instructive. The
first of these deaths was in a child who was vaccinated at 11 AM. That evening at 5 PM the child
had fever for which she was given paracetamol. The baby woke up several times that nightcrying. She was found dead in her bed next morning. There was blood around the nostrils.
On postmortem examination a large swelling around the injection site 9.8 x 7.9 x 4.7 cm withedema and infiltration involving muscle and subcutaneous tissue was noted. The internalorgans including brain, kidneys and lungs were congested. There were petechiae on the surfaceof the lungs and bilateral adrenal bleeds. The report said the autopsy findings were consistent
with death due to hypersensitivity reaction.
The AEFI report however says the death is unlikely to be a programme error or ‘due to vaccineassociated to the vaccination’ (sic)2) The central team looked at the 15 deaths in Kerala . One death in Pathanamthitta is reported
in detail. The healthy 6 week baby was vaccinated on 26 December 2012 at 12 noon. The
mother noted swelling of legs and the baby was ‘grunting’ and reluctant to feed. She was given
4 drops of paracetamol syrup for 'fever and crying' at 5 PM and 2 times on the next day. Thebaby was found dead with blood stained discharge from the nose at 4-30 AM on the morning ofthe 28th. No postmortem examination was performed.
The AEFI report classified this death as “Unknown unclassifiable category” in spite of the factthat the parents are available and gave a detailed history as part of the verbal autopsy.
3) The AEFI report has more interesting details that I quote verbatim: “Temporality ofvaccination with death cannot be established as a causal relationship since it may also be
possible that in the child had a subclinical infection (therefore no obvious signs and symptoms)
and it aggravated in cold conditions, led to Bronchiolitis and death. This may be the reason fordeath due to pulmonary edema (manifesting as blood from the nose and in some postmortem
findings of blood in respiratory tract).”
The cold conditions reported as leading to pulmonary edema and death is intriguing. Kerala has
a climate that borders between a tropical savanna climate and a tropical monsoon climate. As aresult it does not experience distinct seasons. The mean maximum temperature is 34 °C mean
minimum temperature is 21 °C and the lowest temp recorded in December in
Thiruvanthapuram was 20 °C..
The death in babies in Kerala who were apparently completely well in the morning when theywent for immunization but who became unwell soon after vaccination and deteriorated rapidly
to death cannot rationally be attributed to ‘subclinical bronchiolitis infection aggravated by cold
conditions’ leading rapidly to pulmonary edema and death.
Any explanation no matter how outlandish seems adequate but the likelihood of there being a
causative association with the vaccination, which is obvious, is not considered.
This is akin to a person found dead under the rubble after a house collapse. The houseinsurance-company may refuse to pay the next of kin, saying the house collapse could havebeen coincidental and cannot be blamed for the death till it is proved that the deceased had
not suffered a heart attack just before the house collapsed.
4) 8 deaths in Kashmir were investigated by the AEFI team.
There had been 1 death each in June September and December 2013, but in October there
were 11 deaths according to a RTI response (AD/FW/K/RTI/822-24).
Many local newspapers reported the deaths in October were associated with use of a brand ofPentavalent vaccine called Easyfive which vaccine had previously been disqualified because ofquality concerns but had just been reintroduced. Easyfive is not being used in the Kashmir
Government immunization programme currently.
Like in Kerala, the deaths in Kashmir were attributed blithely to sepsis with metabolic disorder(in Aisha who had convulsions and normal CSF and no blood culture evidence of sepsis),meningitis (in Mozim based on persistent vomiting, metabolic acidosis, convulsions and crying
excessively), pneumonia with aspiration (in Nida with fast breathing and gasping respiration
with a family history of sibling death following pneumonia), liver disorder with metabolicacidosis (in Karneez with fever followed by repeated seizures but no CSF examination), sepsis
with metabolic acidosis (in Shaistha crying excessively and irritable for 3 days after vaccination,
convulsions on the third day, put on ventilator till death on 9th day). It is paradoxical, thesediagnoses were reached on the clinical symptoms and laboratory findings of MODS without
specific blood culture evidence of sepsis or CSF evidence of meningitis, suggesting the criteriafor making these diagnoses are not strict like the algorithm needed to arrive at a diagnosis ofdeath caused by vaccine. No death was attributed to MODS due to ‘multisystem generalized
reaction to one or more vaccine components’. The most obvious possibility is not evenmentioned in the differential diagnosis.
5) The doctors in the Kashmir hospital who noted the sudden increase in cases of deaths inOctober (11 cases in one month against the previous rate of 1 case in 2 months) sent telephonictext messages to senior government officials in the central government and state government
to appraise them of these events but the AEFI team comes down heavily on them for sending
these messages "as if to report 'breaking news'". Apparently they were expected not to takenotice of these deaths and continue with business as usual and perhaps not to alert anyone.
It seems that after the October spike in incidence of AEFI deaths, the brand of vaccine waschanged and the numbers of death have come down but the Government AEFI report does not
mention it. It appears that although all brands of the vaccine have been associated with AEFI
deaths in different countries, some brands may be particularly lethal.
A good AEFI reporting system must have picked up all these linkages which the new algorithm
makes studious efforts to avoid.
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